17% Salicylate Versus 17% Salicylate-Ethyl Pyruvate for Plantar Foot Warts
New Formulation of Salicylate to Improve Treatment of Common Skin Warts
1 other identifier
interventional
100
1 country
1
Brief Summary
Plantar warts on the sole of the foot are among the most common warts seen in podiatry clinics. Some patients are readily cured by simple standard of care treatments that include wart debridement (trimming or excision) and application of 17% salicylate (commercially known as Compound W)or by other treatments that may be painful and affect mobility. No treatment is consistently effective and most patients fail treatment multiple times. Ethyl pyruvate (EP)is a common food additive noted to be 'generally regarded as safe' that may improve the activity of salicylate in wart treatment by improving the ability to penetrate and/or persist in the skin. The use of 17% salicylate with the addition of EP may improve cures of common foot plantar warts in subjects who also be receiving other standard-of-care treatment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Nov 2011
Typical duration for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2011
CompletedFirst Submitted
Initial submission to the registry
October 19, 2012
CompletedFirst Posted
Study publicly available on registry
October 23, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2014
CompletedOctober 23, 2012
October 1, 2012
2.1 years
October 19, 2012
October 22, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To determine if salicylate with ethyl pyruvate (SA-EP) eliminates plantar warts more quickly than salicylate (SA) alone.
Subjects' wart(s) are treated with SA or SA-EP every two weeks for up to 16 weeks.
16 weeks
Secondary Outcomes (1)
To determine if salicylate with ethyl pyruvate (SA-EP) in treatment of plantar warts causes adverse events other than those known to occur with SA (salicylate)alone.
16 weeks
Study Arms (2)
17% Salicylate with Ethyl Pyruvate
EXPERIMENTALSubjects with plantar wart(s) will apply the product to warts twice a day for up to 16 weeks.
17% salicylate
ACTIVE COMPARATORsubjects will apply 17% salicylate (standard of care treatment) to plantar skin wart(s) twice a day for up to 16 weeks
Interventions
Eligibility Criteria
You may qualify if:
- evidence of skin plantar wart(s)
You may not qualify if:
- iodine allergy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Grossman, Michael, D.P.M.lead
- Main Line Healthcollaborator
Study Sites (1)
Main Line Foot and Ankle Center
Ardmore, Pennsylvania, 19003, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michael R Grossman, DPM
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDIV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 19, 2012
First Posted
October 23, 2012
Study Start
November 1, 2011
Primary Completion
December 1, 2013
Study Completion
March 1, 2014
Last Updated
October 23, 2012
Record last verified: 2012-10